MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE GRASPING FORCEPS FG-253SX; DISPOSABLE GRASPING FORCEPS

Model Number	FG-253SX
Medical Device Problem Codes	Difficult to Open or Remove Packaging Material (2922); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the single use grasping forceps were used during a stent removal procedure.The customer reported the unit package was not opening easily.When the package was opened, small paper fibers and plastic shreds from the packaging had come off which contaminated the instruments.No adverse effects to patient were reported.
Additional Manufacturer Narrative
No devices have been returned for evaluation at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction to h3 because the device was not returned.The subject device was manufactured in july 2023, but the specific date is unknown.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the package presented no abnormalities prior to shipping.The sterile packages that are additionally heat-sealed have a higher seal strength than those that are not additionally heat-sealed and may be more difficult to open.Therefore, this may have caused the reported event.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE GRASPING FORCEPS FG-253SX
• Common Device Name: DISPOSABLE GRASPING FORCEPS
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17945659
• Report Number: 9614641-2023-01543
• Device Sequence Number: 7777096
• Product Code: PTS
• UDI-Device Identifier: 04953170412059
• UDI-Public: 04953170412059
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: CLASS2-EXMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FG-253SX
• Device Lot Number: 37K
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown